BruxZir™ Incisal Coloring Liquid

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 16, 2023 Prismatik Dentalcraft. Inc. So Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612 Re: K230262 Trade/Device Name: BruxZirTM Incisal Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 17, 2023 Received: April 18, 2023 Dear So Park: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Michael E. Adiodha -S Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K230262 Device Name BruxZir® Incisal Coloring Liquid Indications for Use (Describe) BruxZir® Incisal Coloring Liquid is intended to be used by trained dental technicians as an accessory for shading BruxZir® Shaded 16 PLUS and BruxZir® Esthetic all zirconia, monolithic restorations for anterior and posterior dental prosthetics. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. ### 510(k) Summary - K230262 #### I. SUBMITTER Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA Primary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park(@glidewelldental.com Phone: (949) 863-5479 Secondary Contact Person: Maria Wagner, Sr. Regulatory Affairs Manager Email: Maria.Wagner@glidewelldental.com Phone: (949) 838-1321 Date Prepared: January 30, 2023 #### DEVICE II. Name of Device: BruxZir™ Incisal Coloring Liquid Common Name or Usual Name: Liquid for Dental Zirconia Prosthesis Classification Name: Porcelain powder for clinical use (21 CFR 872.6660) Regulatory Class: Class II Product Code: EIH #### III. PREDICATE DEVICE Primary Predicate: ArgenZ Liquids (K182833) Reference Device: BruxZir™ Opaque Coloring Liquid (K220960) #### IV. DEVICE DESCRIPTION BruxZir™ Incisal Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C. BruxZit™ Incisal Coloring Liquid is available in 3 different colors, Premium, Premium HT, and Pearl. The devices are used on incisal areas of dental restoration to mimic natural tooth color. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color wheel inside. To the right of the triangle is the company name in blue text. #### V. INDICATIONS FOR USE BruxZir™ Incisal Coloring Liquid is intended to be used by trained dental technicians as an accessory for shading BruxZir® Shaded 16 PLUS and BruxZir® Esthetic all zirconia, monolithic restorations for anterior and posterior dental prosthetics. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. | Technological<br>Characteristics | Subject Device<br>(K230262) | Predicate Device<br>(K182833) | Comparison | | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------| | Device Name | BruxZir™ Incisal<br>Coloring Liquid | ArgenZ Liquids | N/A | | | Product Code | EIH | EIH | Same | | | Manufacturer | Prismatik Dentalcraft, Inc. | The Argen Corporation | N/A | | | Intended Use/<br>Indications for Use | BruxZir™ Incisal<br>Coloring Liquid is<br>intended to be used by<br>trained dental technicians<br>as an accessory for<br>shading BruxZir® Shaded<br>16 PLUS and BruxZir®<br>Esthetic all zirconia,<br>monolithic restorations for<br>anterior and posterior<br>dental prosthetics. | ArgenZ Liquids are<br>intended to be used by<br>trained dental technicians<br>as an accessory for<br>shading ArgenZ<br>frameworks and ArgenZ<br>all zirconia, monolithic<br>restorations for anterior<br>and posterior dental<br>prosthetics. | Same except for the<br>device name and<br>compatible products | | | Prescription Device | Yes | Yes | Same | | | Design<br>Characteristics | Chemical<br>Composition | Aqueous solutions of<br>transition and alkaline<br>earth metal salts | Aqueous solutions of<br>transition and lanthanide<br>metal salts | Different chemical<br>composition | | | Biocompatibility | Biocompatible | Biocompatible | Same | | | Principles of<br>Operation | Brushing or Dipping<br>Technique | Brushing or Dipping<br>Technique | Same | | | Type of Packaging<br>and Volume | Bottle; 175mL (150mL<br>Volume) | Bottle; 30mL, 100mL | Similar | | | Shade | Various; Premium,<br>Premium HT, Pearl | Various; VITA shades | Different | | | Sterility | Non-sterile | Non-sterile | Same | # DETERMINATION OF SUBSTANTIAL EQUIVALENCE The subject device, BruxZir™ Incisal Coloring Liquid, is substantially equivalent in intended use, material, design principles and performance to the primary predicate device, ArgenZ Liquids (K182833). The intended use/indications for use for both the {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left, with the company name written in blue text to the right. The word "PRISMATIK" is on the top line, and "DENTALCRAFT, INC." is on the bottom line. subject device and the primary predicate device are the same except for the device name and compatible products. Both devices are liquids used for coloring pre-sintered zirconia restorations. The fundamental principle of operation of the subject device and the primary predicate device is the same. The subject device and the primary predicate device are similar as aqueous solutions, but they are different in terms of chemical composition. However, the performance testing results of the subject device support that the subject device is substantially equivalent to the primary predicate device. The substantial equivalence comparison table above outlines and provides the similarities between the subject device, BruxZir™ Incisal Coloring Liquid, and the primary predicate device, ArgenZ Liquids (K182833). Both the subject device and the primary predicate device have similar physical/mechanical and biocompatibility properties that met the requirements of ISO 6872:2015/Amd 1:2018 and ISO 10993. Any differences between the subject device and the primary predicate device do not raise any new concerns of safety and effectiveness. #### VII. PERFORMANCE DATA Non-clinical data submitted to demonstrate substantial equivalence include: - Mechanical testing for flexural strength and chemical solubility - Vishal shade evaluation - Shelf life ● - Packaging validation - Biocompatibility ● No clinical data is included in this submission. ### Flexural Strength Flexural strength testing was performed on the zirconia substrate treated with the subject device, BruxZir™ Incisal Coloring Liquid, per ISO 6872:2015/Amd 1:2018. The results of the testing demonstrated that the subject device satisfies the minimum mechanical properties of zirconia required for Type II, Class 5 per ISO 6872:2015/Amd 1:2018. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir™ Incisal Coloring Liquid, and the primary predicate device, ArgenZ Liquids (K182833). ### Chemical Solubility Chemical solubility was tested on the worst case. It was concluded that the solubility is below 100 ug/cm2 limit, meeting the ISO 6872:2015/ Amd 1:2018 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir"™ Incisal Coloring Liquid, and the primary predicate device, ArgenZ Liquids (K182833). {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangular prism on the left and the company name on the right. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. ## Visual Shade Evaluation The dental restorations were milled from the zirconia milling blanks with application of the subject device, BruxZir"M Incisal Coloring Liquid. Visual shade evaluations were performed on the sintered and glazed restorations by qualified reviewers against the reference shade guides. It was concluded that BruxZir™ Incisal Coloring Liquid meets shade match requirements and works as intended. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir"M Incisal Coloring Liquid, and the primary predicate device, ArgenZ Liquids (K182833). ### Shelf Life The accelerated aging test was performed per ASTM F1980-21 in order to establish the shelf life of the subject device, BruxZir"M Incisal Coloring Liquid. It was concluded that the shelf life of BruxZir™ Incisal Coloring Liquid is 0.5 years. The results of the testing were used to address questions related to substantial equivalence based on differences in shelf life between the subject device, BruxZir™ Incisal Coloring Liquid, and the primary predicate device, ArgenZ Liquids (K182833). ### Packaging Validation Packaging configurations were evaluated in order to ensure that it is suitable to withstand the distribution environment such that the device packaged in a bottle can be sent to a customer undamaged. The subject device, BruxZir™ Incisal Coloring Liquid, uses the same packaging materials and packaging configurations as the reference device, BruxZir"M Opaque Coloring Liquid (K220960). The results of the previous packaging validation were used to address questions related to substantial equivalence based on differences in packaging configuration between the subject device, BruxZir™ Incisal Coloring Liquid, and the primary predicate device, ArgenZ Liquids (K182833). ### Biocompatibilitv The subject device, BruxZir™ Incisal Coloring Liquid, was tested in accordance with ISO 10993-1. Per the biological evaluation. BruxZir™ Incisal Coloring Liquid was tested for Cytotoxicity (ISO 10993-5:2009) to meet the biocompatibility requirements. Based on the biocompatibility testing results, it was determined that there is no biocompatibility concern for the subject device. The results of the testing were used to address questions related to substantial equivalence based on differences in chemical composition between the subject device, BruxZir™ Incisal Coloring Liquid, and the primary predicate device, ArgenZ Liquids (K182833). #### VIII. CONCLUSION Based on the technological characteristics and non-clinical test data included in this submission, the subject device, BruxZir'™ Incisal Coloring Liquid, has been shown to be substantially equivalent to the primary predicate device ArgenZ Liquids (K182833).